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Bayhill to present BHT-3009 Phase 2 clinical trial data at European Committee Congress

Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company leveraging its proprietary BHT-DNA platform to develop targeted autoimmune disease treatments, today announced that it will present at the 26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis and 15th Annual Conference of Rehabilitation in MS in Gothenburg, Sweden, data from its concluded Phase 2 clinical trial showing that baseline blood plasma anti-MBP (myelin basic protein) profiles identify responders to BHT-3009 treatment.

14 Oct 2010

Sunshine Biopharma to enter Adva-27a Phase I clinical trial for Multi-Drug Resistant breast cancer

Sunshine Biopharma, Inc. a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it issued a letter to its shareholders advising that it had filed for patent protection worldwide and expects to enter Phase I clinical trials for its principal drug, Adva-27a, beginning with GMP manufacturing and animal tox studies.

14 Oct 2010

Acceleron announces ACE-031 Phase 1b study results

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced preliminary results from a Phase 1b study to assess the safety, tolerability and pharmacodynamic (PD) activity of ACE-031 following multiple ascending doses in healthy postmenopausal volunteers.

14 Oct 2010

XenoPort to present XP23829 preclinical data at ECTRIMS meeting

XenoPort, Inc. announced today that it will present data on a new preclinical product candidate, XP23829, at the upcoming 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Gothenburg, Sweden, October 13 - 16, 2010.

14 Oct 2010

Prosensa receives £7.5M milestone payment in GSK2402968 Phase IIa trial for DMD

Prosensa, the Dutch biopharmaceutical company focusing on RNA modulating therapeutics, has announced that it received a £7.5m milestone payment from GlaxoSmithKline (GSK) as a result of achieving a data milestone in its Phase IIa open label extension trial of GSK2402968 (PRO051), being developed to treat Duchenne Muscular Dystrophy (DMD) under its agreement with GSK. The milestone payment was based upon achievement of a successful safety review, with no serious safety signals observed.

13 Oct 2010

Imprime PGG and cetuximab increase overall response rate in metastatic colorectal cancer

A combination of Biothera's Imprime PGG and cetuximab (Erbitux) doubled the overall response rates for second- and third-line metastatic colorectal cancer patients participating in a Phase Ib/IIa clinical trial. The completed trial results were released yesterday at the 35th European Society for Medical Oncology (ESMO) Congress.

13 Oct 2010

Threshold announces TH-302 Phase 1/2 clinical trial interim results

Threshold Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 1/2 clinical trial in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented at the European Society for Medical Oncology (ESMO) Annual Meeting being held in Milan, Italy.

13 Oct 2010

JAMA publishes Probuphine Phase 3 clinical trial data

Titan Pharmaceuticals, Inc. today announced that data from its previously completed and announced Phase 3 randomized, placebo-controlled clinical trial of Probuphine were published in the Journal of the American Medical Association (JAMA).

13 Oct 2010

Ocular Therapeutix completes Proof of Principle clinical study with moxifloxacin punctum plug

Ocular Therapeutix, Inc. announced today the completion of a successful Proof of Principle clinical study with their novel sustained drug delivery moxifloxacin punctum plug.

13 Oct 2010

Archimedes publishes results from FPNS Phase III clinical study for breakthrough cancer pain

Archimedes Pharma, an emerging specialty pharma company focused on oncology, pain, neurology and critical care sectors, today announced publication of results from a Phase III, long-term safety, tolerability and consistency of effect, clinical study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTCP).

13 Oct 2010

Kennedy Krieger Institute launches phase II clinical trial to investigate Revatio for DMD treatment

Kennedy Krieger Institute announced today the launch of a first‐of‐its‐kind, phase II clinical trial to investigate a treatment for heart disease in individuals with Duchenne muscular dystrophy (DMD).

13 Oct 2010

CEL-SCI receives Taiwanese IRB approval for Multikine Phase III trial in head and neck cancer

CEL-SCI Corporation announced today it has received approval from the first Taiwanese Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare.

13 Oct 2010

MTN-007 phase trial evaluates vaginal microbicide to prevent rectal transmission of HIV

Tenofovir gel, a vaginal microbicide that has shown promise for preventing HIV through vaginal sex, is being tested in a new trial looking at its safety and acceptability when used rectally. The results of the study, being led by the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), will help determine if the gel should be evaluated further for its potential to prevent HIV among both men and women who engage in receptive anal intercourse.

13 Oct 2010

US Oncology enrolls 1,000th patient in Phase I clinical trial

US Oncology, Inc., the nation's leading integrated oncology company, announced today that it has enrolled the 1,000th patient in a Phase I clinical trial through its US Oncology Research Network. Phase I clinical trials present special challenges, including increased safety concerns, higher variability of patient disease, more complex trial designs, and some first-in-human trials, making Phase I trials more difficult to operate in the community setting.

13 Oct 2010

HSV1716 clinical trial for childhood cancer receives FDA grant

A clinical trial testing a genetically reprogrammed herpes simplex virus as treatment for deadly forms of childhood cancer has received a U.S. Food and Drug Administration grant to support the research.

13 Oct 2010

Combination of cetuximab and cisplatin chemotherapy benefits women with triple-negative breast cancer

European researchers have proven for the first time that targeting the epidermal growth factor receptor can provide substantial clinical benefit for women with hard-to-treat triple-negative breast cancer.

13 Oct 2010

USPTO issues Watson Notice of Allowance for key progesterone patent to treat or prevent preterm birth

Columbia Laboratories, Inc. announced today that the U.S. Patent and Trademark Office (USPTO) has issued Watson Pharmaceuticals, Inc. a Notice of Allowance for a key patent for the use of progesterone to treat or prevent preterm birth. The USPTO issues a Notice of Allowance to report that a patent application has been examined and is allowed for issuance as a patent. The patent is expected to issue within three months upon payment of required fees.

12 Oct 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.

12 Oct 2010

First presentation of anti-HER2 antibody-drug conjugate as first-line therapy for advanced breast cancer

A new type of breast cancer treatment has shown encouraging activity as a first-line therapy in HER2-positive metastatic disease, researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.

12 Oct 2010

Albireo reports positive results from A3309 Phase IIb study in chronic idiopathic constipation

Albireo today announced positive top-line results from a Phase IIb study in chronic idiopathic constipation (CIC) assessing efficacy and safety of three different dose levels (5, 10 and 15 mg orally once a day) of the investigational drug A3309 during an eight week trial. Analyses of the data show clinically meaningful and statistically significant improvement for patients treated with A3309 compared to placebo-treated patients.

12 Oct 2010

Drug Trial News

Bayhill to present BHT-3009 Phase 2 clinical trial data at European Committee Congress

Sunshine Biopharma to enter Adva-27a Phase I clinical trial for Multi-Drug Resistant breast cancer

Acceleron announces ACE-031 Phase 1b study results

XenoPort to present XP23829 preclinical data at ECTRIMS meeting

Prosensa receives £7.5M milestone payment in GSK2402968 Phase IIa trial for DMD

Imprime PGG and cetuximab increase overall response rate in metastatic colorectal cancer

Threshold announces TH-302 Phase 1/2 clinical trial interim results

JAMA publishes Probuphine Phase 3 clinical trial data

Ocular Therapeutix completes Proof of Principle clinical study with moxifloxacin punctum plug

Archimedes publishes results from FPNS Phase III clinical study for breakthrough cancer pain

Kennedy Krieger Institute launches phase II clinical trial to investigate Revatio for DMD treatment

CEL-SCI receives Taiwanese IRB approval for Multikine Phase III trial in head and neck cancer

MTN-007 phase trial evaluates vaginal microbicide to prevent rectal transmission of HIV

US Oncology enrolls 1,000th patient in Phase I clinical trial

HSV1716 clinical trial for childhood cancer receives FDA grant

Combination of cetuximab and cisplatin chemotherapy benefits women with triple-negative breast cancer

USPTO issues Watson Notice of Allowance for key progesterone patent to treat or prevent preterm birth

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

First presentation of anti-HER2 antibody-drug conjugate as first-line therapy for advanced breast cancer

Albireo reports positive results from A3309 Phase IIb study in chronic idiopathic constipation

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